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Senior Associate, GLP Compliance, Vaccines

Company: Pfizer
Location: Pearl River
Posted on: May 16, 2022

Job Description:

Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveYou will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It

  • Supports the administration and configuration of the environmental monitoring system(s) (EMS) including oversight of other administrators. Will facilitate installation, calibration, maintenance and validation of environmental monitoring system(s).
  • Supports maintenance of instrument/equipment inventory and qualification through coordination with VRD staff, Pharmaceutical Sciences Quality Assurance (PharmSci QA), internal Research Informatics, building maintenance, and finance/contracts. Manages and coordinates the processes to qualify environmental chambers with external vendors and onsite personnel. Reviews and approves documentation regarding equipment qualification.
  • Supports the change control process by serving as a change control SME and supports the change control coordinator in conducting regularly scheduled change control committee meetings. Confers with the change control committee QCO, PharmSci QA, and other subject matter experts as needed.
  • Supports Laboratory Equipment Oversight monthly cross-functional team meeting for VRD to track and resolve laboratory and equipment issues.
  • SME for VRD staff for Engineering Asset Management System (EAMS). Provide guidance, assistance, and training with use of system for VRD staff.
  • Participates in internal inspections of the VRD laboratories including, but not limited to, laboratory notebooks, documentation workbooks, and SOPs. Serves as VRD representative as required for audits/inspections conducted by organizations external to VRD, to provide auditors with the required documents and related information.
  • Leads training sessions for departmental procedures, Honeywell EMS, Reno, EAMS, and any other quality related training as needed.
  • Reviews and approves SOPs, Test Methods, and reports for compliance with CFR, EMA and VRD SOP requirements as a QCO reviewer.
  • Writes and revises SOPs as necessary for this job function. Circulate for review, coordinate reviewer's comments and approve.
  • Supports P2L training processing and compliance as required.
  • Satisfactorily completes all cGMP/GLP and safety training in conformance with Departmental requirements. Where applicable, perform job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.
  • Performs other job duties as assigned.QUALIFICATIONSMust-Have
    • Bachelor's Degree in a scientific field and 5+ years of cGMP or GLP/GCLP experience or Master's Degree with 3+ years of experience
    • Excellent written and oral communication skills
    • Excellent analytical abilities and problem-solving skills
    • Ability to provide leadership, set priorities and be accountable to timelines
    • Working knowledge of Microsoft Office, Microsoft Project, Statistical Software.Nice-to-Have
      • Strong in Microsoft Office computer skills and relevant scientific softwarePHYSICAL/MENTAL REQUIREMENTS
        • Work primarily performed at individual's desk, computer workshop, or may require walking around to various laboratories/biosuite.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
          • Evening and weekend work required periodically for off hour EMS system updates and to keep up with project demands.OTHER JOB DETAILS
            • Eligible for Relocation Package
            • Eligible for Employee Referral Bonus---Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Quality Assurance and Control

Keywords: Pfizer, New York , Senior Associate, GLP Compliance, Vaccines, Other , Pearl River, New York

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